Job Description Regulatory Affairs Specialist Looking for a different challenge as a Regulatory Affairs Specialist whereby you can still utilise your skills? Permanent Full-time position with competitive renumeration and benefits Ideally based from Sydney Australia , also open to NZ located applicants Hybrid, work from home and office environment, with a dedicated and welcoming team Join a growing, yet already successful market Upskill and growth in an area you're passionate about , whilst being fully supported and encouraged. Join a Trusted Global Leading Animal Health organisation The Regulatory Affairs Specialist plays a crucial role in ensuring internal and external regulatory compliance for the manufacture, importation, and supply of the entire animal health product range in Australia and New Zealand. The pharmaceutical industry in Australia and New Zealand is highly regulated and competitive, making it essential for the company's success to navigate regulatory processes efficiently and effectively. The Regulatory Affairs Specialist sits within the Regulatory Affairs Operations organization and reports to Regulatory Affairs Operations Team Leader. What You Will Do Responsibilities include, however not limited to: Regulatory Submissions: The Regulatory Affairs Specialist is responsible for submitting applications to regulatory authorities (e.g., APVMA, ACVM, DAFF) to maintain registrations in compliance with product changes and regulatory requirements. Compliance Management: Taking ownership of regulatory processes is another key responsibility. This includes managing changes in artwork, approving marketing materials, ensuring regulatory reporting and maintenance of permits and licenses, and adhering to internal policies and legislative requirements. Change Control Support: The Specialist provides regulatory input for change control processes across our company's Animal Health's manufacturing and quality network. This involves contributing to decision making and strategy development by offering regulatory and technical advice to other parts of the organization. Pharmacovigilance Support (if applicable): If the Specialist has pharmacovigilance responsibilities, they must maintain current pharmacovigilance training and assist in processing local pharmacovigilance cases in compliance with company and regulatory requirements. What You Must have: Education and Experience: Graduate or Post-Graduate degree in a relevant biological science field Solid amount of experience in a related industry Experience in the animal health industry or pharmaceutical manufacturing is highly beneficial Regulatory Knowledge Familiarity with the Australian and New Zealand Regulatory Systems (e.g., APVMA, DAFF, ACVM). Leadership and Communication Strong negotiation and influencing skills. Excellent communication (both written and verbal) and organizational skills. Ability to work collaboratively in a team setting. Analytical and Problem-Solving Skills Ability to analyse data with a logical and analytical approach to problem-solving. Demonstrated ability to work across diverse projects and stakeholders. What You Can Expect Work autonomously whilst being supported, encouraged and being part of a trusted Global Leading Animal Health organisation Exposure to upskill and develop in your role Flexibility and opening doors to other opportunities and skillsets Joining a collaborative team of likeminded individuals We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Requisition ID: R282210 #J-18808-Ljbffr
